FDA•MODERATE
Philips Brilliance CT Systems
Philips recalls Brilliance CT systems due to scan trigger failure risking inadequate diagnosis and extra radiation.
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FDA•MODERATEAMS Spinal KitWindstone Medical recalls AMS Spinal Kit (Part AMS13683A) due to supplier quality issues with included Lidocaine HCl injection.
8 products
FDA•MODERATEMedtronic EOPA Arterial CannulaMedtronic recalls EOPA 22 Fr arterial cannulae over pinhole leak risk during bypass.
6 products
FDA•MODERATEL-Cath PICC S/L Peripherally Inserted Central CatheterArgon Medical recalls L-Cath PICC catheters (REF 384539, 384464, 384516, 384463) due to hub cracking risk.
2 products
FDA•MODERATEAMS Medical Convenience KitsWindstone Medical recalls 80+ AMS convenience kits over endotoxin risk in supplied sponges.
4 products
FDA•MODERATEMedline Convenience Kits with BD PurPrep 26 mLMedline recalls convenience kits with BD PurPrep 26 mL over Bacillus contamination.
4 products
FDA•MODERATEMedline Convenience Kits with Bard Silastic Foley CathetersMedline recalls convenience kits with Bard Silastic Foley Catheters over surface material risk.
9 products
FDA•CRITICALMedline HIP CDS-LF Convenience KitMedline recalls kits with Bupivacaine ampules over quality issues causing drug ineffectiveness.
2 products
FDA•MODERATEMiniMed Go AppMedtronic MiniMed recalls MiniMed Go App v1.0.0 and v1.1.0 over nighttime alert failure risking missed insulin doses.
FDA•MODERATEFlexible Hystero-Fiberscope KitsKarl Storz recalls hysteroscope kits with expired endoscopic seals that may compromise sterility.
FDA•MODERATESafeOp Patient InterfaceAlphatec Spine recalls SafeOp Patient Interface over software issue causing tEMG loss, system faults, and reboot prompts.
FDA•MODERATESnapshotGLO Wound Imaging DeviceKent Imaging recalls SnapshotGLO wound imaging devices due to battery charging failure.
FDA•MODERATEPipeline Flex Embolization Device with Shield TechnologyMicro Therapeutics recalls Pipeline Flex Embolization Device due to incorrect labeling of implant sizes.
2 products
FDA•CRITICALMedline Anterior Hip KitMedline recalls anterior hip kits with Bupivacaine injection due to quality issues.
3 products
FDA•MODERATEHalyard Standard Line Insertion PackAVID Medical recalls Halyard Standard Line Insertion Pack (Model PVHM234-01) over silicone seal defects causing leakage.
- Device RecallFDA•MODERATEEmano Flow v2.0.0
Emano Flow v2.0.0 recalled due to audio sampling mismatch causing biased flow rate and volume estimates.
FDA•MODERATETheraSphere 360 Y-90 Management PlatformBoston Scientific recalls TheraSphere 360 Y-90 Platform due to software anomaly causing incorrect dose calculations.
FDA•MODERATEOlympus High Flow Insufflation Unit UHI-4Olympus recalls UHI-4 insufflation unit over unexpected display shutdown and air delivery loss.
FDA•MODERATEVentriculostomy KitMedtronic is recalling the Ventriculostomy Kit due to endotoxin levels that exceed safety limits for cerebrospinal fluid contact.
FDA•MODERATEPenumbra RED 68 Reperfusion CatheterPenumbra is recalling the RED 68 Reperfusion Catheter due to a manufacturing issue that may cause the device to fracture during use.
FDA•MODERATEWilcox BOSS Xe Aiming LasersWilcox is recalling all BOSS Xe aiming lasers to implement a safety-related software enhancement.
- Device RecallFDA•MODERATE3mensio Vascular Fenestrated Workstation Software
3mensio software may report inaccurate cardiovascular measurements when analyzing specific Philips 3D echo datasets.
FDA•MODERATESilent Nite Sleep ApplianceThe Silent Nite Sleep Appliance (Model SILNT) is being recalled because it lacks required FDA clearance.
FDA•MODERATEOlympus 4K UHD LCD MonitorOlympus is recalling the 4K UHD LCD Monitor (model OEV321UH) due to a potential connector fault that may cause image loss or abnormalities.
FDA•MODERATEFARADRIVE Steerable Sheath Clear IDEBoston Scientific is recalling the FARADRIVE Steerable Sheath Clear IDE due to potential valve damage that may cause air embolism.
4 products
FDA•MODERATEAVID Medical Eye Pack Convenience KitAVID Medical is recalling the Eye Pack convenience kit (Model LVEY27) due to an incorrect concentration of Betadine solution.
FDA•MODERATESeaSpine Polyaxial HeadSeaSpine is recalling the Polyaxial Head due to a manufacturing error that may cause the component to detach during surgery.
FDA•MODERATEFerno Power F2 Powered Fastening SystemFerno is recalling the Power F2 Powered Fastening System due to a risk of the rail mechanism lodging and preventing stretcher movement.
FDA•MODERATEHotline Fluid Warming SetICU Medical is recalling Hotline Fluid Warming Sets due to a risk of leakage at the tubing-to-connector bond.
FDA•MODERATEParagon 28 Phantom Intramedullary Nail System Guide RodParagon 28 is recalling the Phantom Hindfoot TTC/TC Ball Tipped Guide Rod (item P31-955-1800-S) due to sterile packaging breaches.
FDA•MODERATEBoston Scientific FARASTAR PFA GeneratorBoston Scientific is recalling FARASTAR PFA generators (Product ID 61M401) due to incompatibility with the FARAPOINT PFA catheter.
FDA•MODERATEFARASTAR Ablation Generator and Cardiac Ablation CatheterBoston Scientific is recalling FARASTAR Ablation Generators and Cardiac Ablation Catheters due to missing information in the device labeling.
3 products
FDA•MODERATETosoh ST AIA-Pack TestosteroneTosoh is recalling ST AIA-Pack Testosterone test kits due to potential for inaccurate results that may impact clinical treatment decisions.
FDA•MODERATEPhotera 400 Phototherapy DeviceDaavlin recalls Photera 400 phototherapy device due to incorrect UV sensor GAIN causing wrong output.
3 products
FDA•MODERATEMedline Total Knee Pack DYNJT6267Medline recalls Total Knee Pack DYNJT6267 over sterility breach risk from Zimmer Biomet mixing bowls and spatulas.
2 products
FDA•MODERATEVasoview Hemopro 2 Endoscopic Vessel Harvesting SystemVasoview Hemopro 2 Endoscopic Vessel Harvesting System is recalled due to an out-of-specification sterilization dose.
FDA•MODERATEMedtronic DLP One-Piece Pediatric Arterial CannulaMedtronic recalls DLP Pediatric Arterial Cannula (CFN 77010) over loose foreign material risk.
2 products
FDA•MODERATEPapablic Replacement Brush HeadsPapablic recalls Replacement Brush Heads model Papablic18B due to breakage risk.
2 products
FDA•MODERATEOrthofix MINIRAIL Standard LengthenerOrthofix recalls MINIRAIL Standard Lengthener Model M101 due to incorrect labeling.
8 products
FDA•MODERATEOptima XR200amx Radiographic SystemGE HealthCare recalls Optima XR200/220/240amx systems over risk of X-ray arm drop causing injury.
3 products
FDA•MODERATEBoston Scientific Rapid Refill Continuous Injection SystemBoston Scientific is recalling the Rapid Refill Continuous Injection System due to a risk of syringe disconnection during use.
FDA•MODERATEICU Medical Plum Duo Infusion PumpICU Medical recalls Plum Duo Infusion Pump v1.2.3 due to risk of delivering up to twice the programmed volume.
2 products
FDA•CRITICALAbiomed Impella Introducer KitOscor recalls Abiomed Impella Introducer Kits (REF 0052-3025) due to sheath leakage risk.
3 products
FDA•CRITICALTransvenous Pacing Electrode TrayArgon Medical recalls pacing electrode trays over non-sterile lidocaine ampules.
6 products
FDA•CRITICALABIOMED Impella RP Flex Introducer SheathAbiomed recalls Impella RP Flex pump sets over introducer sheath leakage risk.
13 products
FDA•MODERATEOlympus Toomey Evacuator 30cc with AdaptorOlympus recalls Toomey Evacuator 30cc with Adaptor, Model 188, over sterilization concerns.
4 products
FDA•MODERATEVersius Surgeon ConsoleCMR Surgical is recalling the Versius Surgeon Console due to a cybersecurity risk involving the Secure Boot feature.
- Device RecallFDA•MODERATETMINI Miniature Robotic System Tracking Arrays
Think Surgical is recalling TMINI Femur and Tibia Tracking Arrays because a loose knob may cause surgical misalignment.
FDA•MODERATEVitek 2 AST-N447 Test KitBiomerieux is recalling Vitek 2 AST-N447 Test Kits due to potential for false resistant results caused by pouch foil fractures.
FDA•MODERATEOmniTract Surgical Retractor SystemIntegra LifeSciences is recalling the OmniTract Surgical Retractor System due to insufficient drying time instructions in the user manual.